28 March 2022 - Approval based on data where fenfluramine demonstrated efficacy in the most difficult to treat seizure types, including drop seizures, which cause a person to suddenly lose muscle tone, become limp, and fall to the ground with a high likelihood of injury.
UCB today announced that Fintempla (fenfluramine) oral solution has been approved in the United States, by the U.S. FDA for the treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age and older.
Additionally, the FDA has granted paediatric exclusivity for the product.